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Talk to a SpecialistTalk to a SpecialistWise Vice LLC dba Wise Vice Vapors manufactured and distributed e-liquid tobacco products containing nicotine without required premarket authorization as mandated by the Federal Food, Drug, and Cosmetic Act. The FDA determined the company's products fell under tobacco product jurisdiction, including products containing nicotine from any source following the 2022 legislative expansion of FDA authority. The company failed to comply with FD&C Act requirements for new tobacco products, which require premarket authorization before commercial distribution in the United States.